Back to resultsRepeated Low-Level Red-Light Therapy Shortens Axial Length
Primary Purpose
High Myopia, Axial Length, Eye Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RLRL
Sponsored by
About this trial
This is an interventional treatment trial for High Myopia
Eligibility Criteria
Inclusion Criteria: Provision of consent. Age: ≥ 8 and ≤ 18 years at enrolment. High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes. Willing and able to participate in all required activities of the study. The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks. Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy. Exclusion Criteria: Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome. Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots. Strabismus and binocular vision abnormalities in either eye. Previous any intraocular surgery affecting refractive status. Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Sites / Locations
- The Second People's Hospital of Foshan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Repeated low-level red-light (RLRL) therapy
Arm Description
single vision spectacles & RLRL
Outcomes
Primary Outcome Measures
Incidence rate of axial length shortening greater than 0.05 mm
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Secondary Outcome Measures
Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm
Incidence rates of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.10 mm and 0.20 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Magnitude of axial length shortening among shortened eyes
The magnitude of axial length shortening is characterized as the amount of axial length reduction in eyes with axial shortening. Axial length (mm) is measured using the IOL Master.
Changes in choroidal thickness (μm)
Changes in choroidal thickness are characterized as the difference between each follow-up visit and corresponding baseline values which are measured using the optical coherence tomography.
Changes in axial length (mm)
Changes of axial length is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Changes in corneal curvature (mm)
Changes of corneal curvature is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Changes in anterior chamber depth (mm)
Changes of anterior chamber depth is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Changes in white to white (mm)
Changes of white to white is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Change of cycloplegic spherical equivalent refraction
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).
Change of pathologic myopia fundus META-PM grading
The fundus images are classified based on META-PM classification system. Color fundus images are obtained using the fundus camera.
Change in best corrected visual acuity
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. Visual acuity is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart with standard illumination at a distance of 4 meters.
Incidence of self-reported adverse events
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Full Information
NCT ID
NCT05768152
First Posted
February 20, 2023
Last Updated
March 2, 2023
Sponsor
The Second People's Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT05768152
Brief Title
Repeated Low-Level Red-Light Therapy Shortens Axial Length
Official Title
Repeated Low-level Red-light Therapy in High Myopia Children and Teenagers: a Prospective Single-arm Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second People's Hospital of Foshan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.
Detailed Description
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Axial Length, Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repeated low-level red-light (RLRL) therapy
Arm Type
Experimental
Arm Description
single vision spectacles & RLRL
Intervention Type
Device
Intervention Name(s)
RLRL
Intervention Description
RLRL will be performed twice per day with an interval of at least 4 hours, each treatment last 3 minutes, in addition to single vision spectacles with power for correcting distance refraction.
Primary Outcome Measure Information:
Title
Incidence rate of axial length shortening greater than 0.05 mm
Description
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm
Description
Incidence rates of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.10 mm and 0.20 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Time Frame
12 months
Title
Magnitude of axial length shortening among shortened eyes
Description
The magnitude of axial length shortening is characterized as the amount of axial length reduction in eyes with axial shortening. Axial length (mm) is measured using the IOL Master.
Time Frame
12 months
Title
Changes in choroidal thickness (μm)
Description
Changes in choroidal thickness are characterized as the difference between each follow-up visit and corresponding baseline values which are measured using the optical coherence tomography.
Time Frame
1, 3, 6 and 12 months
Title
Changes in axial length (mm)
Description
Changes of axial length is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time Frame
1, 3, 6 and 12 months
Title
Changes in corneal curvature (mm)
Description
Changes of corneal curvature is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time Frame
1, 3, 6 and 12 months
Title
Changes in anterior chamber depth (mm)
Description
Changes of anterior chamber depth is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time Frame
1, 3, 6 and 12 months
Title
Changes in white to white (mm)
Description
Changes of white to white is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time Frame
1, 3, 6 and 12 months
Title
Change of cycloplegic spherical equivalent refraction
Description
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).
Time Frame
1, 3, 6 and 12 months
Title
Change of pathologic myopia fundus META-PM grading
Description
The fundus images are classified based on META-PM classification system. Color fundus images are obtained using the fundus camera.
Time Frame
1, 3, 6 and 12 months
Title
Change in best corrected visual acuity
Description
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. Visual acuity is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart with standard illumination at a distance of 4 meters.
Time Frame
1, 3, 6 and 12 months
Title
Incidence of self-reported adverse events
Description
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Time Frame
1, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of consent.
Age: ≥ 8 and ≤ 18 years at enrolment.
High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes.
Willing and able to participate in all required activities of the study.
The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.
Exclusion Criteria:
Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
Strabismus and binocular vision abnormalities in either eye.
Previous any intraocular surgery affecting refractive status.
Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbin Kong, MD, PhD
Phone
+8613929994766
Email
xiangbin_kong@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Chen, MD
Email
chenyp1_1@163.com
Facility Information:
Facility Name
The Second People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangbin Kong, MD, PhD
Phone
+8613929994766
Email
xiangbin_kong@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared as open data after proper anonymization.
Learn more about this trial
Repeated Low-Level Red-Light Therapy Shortens Axial Length
We'll reach out to this number within 24 hrs